Kornimate/medical-research-clean huggingface dataset:
results of the treatment of medium and long de novo and restenotic lesions in the superficial femoral artery and/or popliteal artery with primary or salvage pulsar® -18 t3 stent

Conditions: Peripheral Artery Disease (PAD)

Summary: the purpose of this post-authorization registry is to describe the clinical outcomes of de novo and restenotic lesions in the superficial femoral and/or popliteal artery treated with the pulsar® -18 t3 stent, implanted both primary and salvage.

post-authorization, prospective and multicenter registry to evaluate the clinical results of the pulsar® -18 t3 stent, in the treatment of de novo or restenotic lesions of the superficial femoral and/or popliteal artery, primarily as salvage, in a population of patients residing in spain and in "real life" conditions. in this registry, data will be collected from approximately 100 consecutive patients who have been treated with the pulsar® -18 t3 stent. subjects with pad treated with the pulsar® -18 t3 stent will be assessed for eligibility for the registry and will be consecutively included in the registry. once informed consent is obtained, the required data will be collected.

Eligibility criteria:
inclusion criteria: i1. patients with documented pad from the afs and/or ap, classified as having intermittent claudication or critical limb ischemia (cli), with a rutherford score between 3 and 5. i2. age ≥ 55 years. i3. the target lesion consists of one or multiple de novo or restenotic lesions \> 5 cm. i4. adequate run-off distal circulation to the foot (at least one patent, pre-existing, or successfully restored native distal vessel before beginning treatment of the target lesion). i5. adequate in-flow defined as, stenosis ≤ 30% of the diameter (either pre-existing or successfully reestablished before starting treatment of the target lesion). i6. ci signed and dated. exclusion criteria: e1. failure to successfully cross the target lesion with a guidewire (successful crossing means that the tip of the guidewire is distal to the target lesion, without dissection or perforation that limits blood flow). e2. life expectancy \< 12 months. e3. any contraindication to the use of antiplatelet therapy and/or heparin e4. acute or subacute thrombosis in the target vessel.
study of abt-700 in subjects with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: this is a phase 1/1b open-label study evaluating the safety, pharmacokinetics (pk), and preliminary efficacy of abt-700 in subjects with advanced solid tumors that may have met amplification or c-met overexpression. abt-700, previously known as h224g11 in publications, is an anti-c-met antibody. the early clinical development plan for abt-700 is based on the activity demonstrated in preclinical models. up to 124 subjects will be enrolled.


Eligibility criteria:
inclusion criteria: * subject with advanced solid tumors; dose-expansion: evidence for met gene amplification. * subject must have disease: a) that is not amenable to surgical resection, or b) that has progressed or recurred despite standard therapy, or c) that has failed to respond to standard therapy, or d) for which no effective therapy exists. * subject cannot tolerate or must not be eligible for other approved therapeutic options with known survival advantage. * subjects enrolled on the combination therapy phase must satisfy the above inclusion criteria and also the following: subjects must have inoperable, locally advanced or metastatic cancer and be eligible to receive docetaxel or folfiri/cetuximab or erlotinib in combination with abt-700. exclusion criteria: * subject has received anticancer therapy including chemotherapy, immunotherapy, radiation therapy, immunotherapy, biologic, or any investigational therapy within a period of 21 days, or herbal therapy within 7 days prior to the first dose of abt-700. * subjects with uncontrolled metastases of the central nervous system. subjects with brain metastases are eligible provided they have shown clinical and radiographic stable disease after definitive therapy and have not used steroids for at least 1 month prior to first dose of abt-700. * subject has unresolved adverse events \> grade 1 from prior anticancer therapy except for alopecia or anemia. * subject has had major surgery within 21 days prior to the first dose of abt-700. * subjects enrolled on the combination therapy phase must not meet the above exclusion criteria and must be eligible to receive docetaxel or folfiri/cetuximab or erlotinib per most current prescribing information, or at the discretion of the investigator. subjects with k-ras mutation-positive colorectal cancer will be excluded from receiving folfiri/cetuximab.

Keywords: c-met overexpression met amplification neoplasms h224g11
atezolizumab and bevacizumab with combined radiotherapy for advanced hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: atezolizumab plus bevacizumab combination therapy (atezobev) is well-known 1st-line therapy for advanced hepatocellular carcinoma (hcc). however, there are unmet needs for patients with advanced hcc who do not respond to atezobev. external beam radiotherapy (rt) is another well-known locoregional therapy for hcc that induces inflammatory cascade and abscopal effect as a systemic anticancer effect and enhances the effect of atezobev. therefore, the investigators aim to verify the effect of atezobev plus rt for advanced hcc through this single-center, prospective phase ii one-armed cohort study over three years. this study recruits 51 patients to verify the effect of the intervention. atezolizumab (1200mg) and bevacizumab (15mg/kg) are administered to patients once for each cycle at 3-week intervals, and additional radiotherapy for the mass or portal vein tumor thrombosis is performed before second cycle of atezobev. the primary endpoint is progression-free survival by using response evaluation with modified recist.


Eligibility criteria:
inclusion criteria: 1. age ≥19; 2. clinically or histologically diagnosed hcc; 3. hcc with vp2-vp4 portal vein invasion; 4. intact liver function with child-pugh class a; 5. adequate size of rt field; 6. intact performance with ecog below 2; 7. non-pregnant with acceptable contraception in premenopausal women); 8. without other life-threatening diseases; 9. ability to provide written informed consent and to comply with all study conditions. exclusion criteria: 1. active uncontrolled infection; 2. current or history (\< or = 5 years) of advanced malignancies in the other organs; 3. history of liver transplantation; 4. miliary hcc which incompatible external beam rt
prospective, non-randomized evaluation of carbon dioxide gas as a contrast agent in comparison with iodinated contrast in endovascular aneurysm repair

Conditions: Carbon Dioxide; Endovascular Abdominal Aortic Aneurym Repair; Prospective; Angiogram

Summary: endovascular repair of infrarenal abdominal aortic aneurysms (aaa) requires a contrast agent to identify the vascular anatomy and placement of the stent graft. iodine contrast has traditionally been used, but has the potential to harm the kidneys. another contrast agent is carbon dioxide gas. it has been proven safe to use, but the quality of the images it creates needs to be compared to iodine contrast. patients in this study undergo the endovascular aaa repair as they normally, with the iodine contrast. at the end of surgery carbon dioxide gas contrast is given as an extra step. the images will be later evaluated.


Eligibility criteria:
inclusion criteria: * infrarenal abdominal aortic aneurysm amendable to endovascular repair exclusion criteria: * renal failure or contraindication to receiving iodine contrast.
a study of subcutaneous mircera for the treatment of anemia in peritoneal dialysis patients.

Conditions: Anemia

Summary: this 2 arm study will compare the efficacy of monthly mircera and epoetin alfa in peritoneal dialysis patients who self-inject at home or receive in-centre injections. the safety of subcutaneous (sc) mircera and injection site reactions and patient satisfaction will also be assessed. eligible patients will be randomized either to receive monthly sc injections of mircera (and will be switched from sc epoetin alfa) at a starting dose of 120-360 micrograms, or to remain on standard of care sc epoetin alfa. dose adjustments will be permitted to reach/maintain a hemoglobin level of 10-12g/dl. the anticipated time on study treatment is 3-12 months, and the target sample size is 380 individuals.


Eligibility criteria:
inclusion criteria: * adult patients, \>=18 years of age; * chronic kidney disease stage v; * on peritoneal dialysis for 3 months prior to screening; * on epoetin alfa sc \>=3 months prior to screening. exclusion criteria: * patients expecting to change dialysis modality over course of study; * patients hospitalized during previous 3 months for any clinically significant condition; * active malignancy; * bleeding episode necessitating transfusion, or overt gastrointestinal bleeding within 3 months prior to screening; * transfusion of red blood cells within 3 months prior to screening.
laser acupuncture for postpartum weight retention

Conditions: Postpartum Weight Retention

Summary: objective: to determine the therapeutic effect of acupuncture on postpartum weight retention. methods: 66 subjects after delivery with postpartum weight retention will be randomly divided into laser acupuncture and control group. a single-blind clinical trial will be conducted and the subjects will be treated with verum or sham laser acupuncture 5 sessions per week. after about 3 weeks of treatment, the differences of the subjects' body weight, body mass index, and waist circumference will be analyzed with anova between laser acupuncture and control group.

objective: gestational weight gain and weight retention at 1 year after delivery are associated with long-term obesity. the investigators aimed to investigate the effect of laser acupuncture therapy (lat) on postpartum weight control. methods: the investigators randomly assigned 66 subjects with postpartum weight retention to a laser acupuncture group and control group. the subjects were treated at acupoints including the stomach and hunger points of the ear, st25 (tianshu), st28 (shuidao), st40 (fenglong), sp15 (daheng), cv9 (shuifen), and sp6 (sanyinjiao) by using verum or sham laser acupuncture over 5 sessions per week. after 12 treatment sessions, the differences in the body mass index (bmi), body fat percentage (bfp), and waist-to-buttocks ratio (wbr) of the patients were analyzed, and compared between the laser acupuncture and control groups via analysis of variance, chi-square tests, and stepwise regression tests.

Eligibility criteria:
inclusion criteria: * postpartum duration of \<1 month; * body mass index (bmi) \> 25; * age \> 20 years; * did not use any other medications for weight loss during the study period; and * provided informed consent. exclusion criteria: * presence of a pacemaker; * history of seizure or epilepsy; * taking immunosuppressant medication; * cancer; * infectious disease of the skin; * taking medications for weight loss, including chinese herbal preparations, during the study period; * receiving other treatment, including supplements, herbs, and medications for weight gain prior to entering the study; * comorbidities (hypothyroidism, renal disease, etc.) that the physician believes would affect the findings; * unable to undergo lat due to other medical conditions; and * lack of informed consent.

Keywords: laser acupuncture postpartum weight retention obesity
aesthetic effect of steri-strip orientation on healing and scar appearance in breast surgery

Conditions: Scar; Breast Neoplasms; Breast Diseases; Surgical Wound

Summary: all patients undergoing breast biopsy, lumpectomy, needle-localization-guided breast biopsy, and mastectomy at einstein medical center philadelphia, einstein medical center montgomery, center one, or einstein elkins park will be offered participation into the study. patients who have documented allergies to adhesive or tape, patients taking chronic steroids, and patients with documented connective tissue, skin, or healing disorders will be excluded from the study. risks and benefits of the study as well as risks and benefits of the procedure will be discussed with the patient by one of the investigators. if the patient elects to participate in the study, they will be assigned to incisional dressing at the time of operation with either in-line or perpendicular placement of steri-strips based on the patient's computer-generated randomization assignment. the patient's chart will be reviewed to determine the patient's age and comorbid conditions including obesity (pre-operative bmi), diabetes mellitus, use of anti-platelet or anticoagulant medication, or smoking. this information will be utilized to ensure that our study groups are similar in baseline demographics and pre-existing conditions. additionally, the primary medical reason for needing breast surgery will be reviewed as well as treatment with pre-operative or post-operative chemotherapy or radiation therapy to the breast. steri-strips will not be removed and will be allowed to fall off naturally. at regularly scheduled 30-day and 90-day follow-up appointments, pictures will be taken of the incisional area. these photographs will be reviewed by a blinded, independent surgeon who will grade each incision according to the modified hollander cosmesis scale. statistical analysis with t-testing of the means and chi-squared testing of dichotomous variables will be performed to determine significance of the findings.


Eligibility criteria:
inclusion criteria: - all adult patients undergoing breast biopsy, lumpectomy, needle-localization-guided breast biopsy, and mastectomy at einstein medical center philadelphia, einstein medical center montgomery, center one, or einstein medical center elkins park will be offered participation into the study. exclusion criteria: * patients who have documented allergies to adhesive or tape, patients taking chronic steroids, and patients with documented connective tissue, skin, or healing disorders * members of vulnerable populations such as adults who are unable to consent, individuals who are not yet adults, pregnant women, or prisoners

Keywords: wound healing cosmesis postoperative dressing
abdominal wall closure with triclosan-coated suture (tcs09-10)

Conditions: Wound Infection

Summary: after open colo-rectal surgery the surgical site infection (ssi) is very high among abdominal surgeries. the goal of the investigators randomized, prospective, multicentric, internet-based study is to compare rate of ssi after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. 180-180 cases in seven centres are involved in this study. two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated pds suture (pds vs. pds-plus). triclosan is an antiseptic material which the investigators hope will provide better local infection control at the site with reducing the risk of bacterial colonisation.

after open colo-rectal surgery the surgical site infection (ssi) is very high among abdominal surgeries. the goal of our randomized, prospective, multicentric, internet-based study is to compare rate of ssi after surgery of colon and rectum by using triclosan-coated suture for abdominal wall closure. two arms are separeted by computer randomization at abdomial wall closure: application of triclosan-coated and non-coated pds suture (pds vs. pds-plus). triclosan is an antiseptic materia which we hope provides better local infection control at the site with reducing the risk of bacterial colonisation. attached website: www.itplan.hu/sebstudy/ randomizing patients: 1. logging in (completing the id pannel) 2. on-line randomization 3. patient appears on list 4. operation (recording details) 5. recording - post-operation events * complications * control examination

Eligibility criteria:
inclusion criteria: * elective (subjected to bowel preparation) operations * benign or malignsnt colon or rectal disease * age: 18-80 * bowel opening is made during operation exclusion criteria: 1. cannot be randomized: systemic diseases influencing local surgical site healing insulin-dependent diabetes mellitus child b-c liver cirrhosis kidney disease requiring dialysis immune-suppression treatment ibd acute surgery or unpreparated bowel after being informed patient does not sign the statement of consent 2. to be excluded later: surgically incurable tumour septic state or complication occurred in the post-operational stage patient withdraws the signed consent before the examination is closed 3. undesirable complication: sterile surgical site separation suture break during the post-operational stage

Keywords: surgical site infection elective colorectal surgery level of surgical site infection complication of surgical site infection type of changed bandage frequency of bandage changing
added value of supersonic shear imaging in the diagnosis of white matter damage in preterm infants

Conditions: Preterm

Summary: preterm birth and perinatal events related can interrupt microscopic maturation of the developing white matter leading to diffuse injury and subsequent neurocognitive impairments. brain maturation can be studied using diffusion tensor imaging but is difficult to assess early after birth, repeatedly and at the bedside. supersonic shear wave imaging (ssi) could be of interest in this clinical setting. this technique, already investigated in adults (breast, thyroid or liver fibrosis staging), has not been yet evaluated in neonates. objective: to describe the feasibility and reproducibility of quantitative elasticity mapping in preterm infants and to correlate to gestational age. methods: ssi is a quantitative stiffness imaging technique based on the combination of a remote palpation induced into tissues by the radiation force a focused ultrasonic beam and an ultrafast ultrasound imaging sequence. such ultrafast frame rates permit to track in real time the displacements induced by the propagation of the resulting shear waves. for each pixel, the shear wave speed can be estimated locally and enables quantitative mapping of the local shear elasticity (characterizing the stiffness in kpa). in this study, we will use a new generation of ultrafast ultrasound scanners (aixplorer®, supersonic imagine, aix en provence, france) with a linear l10-2 probe (256 elements, 6 mhz) in neonates born between 25 and 40 weeks' gestation (n=100). three separate acquisitions will be obtained for each area of interest both on right and left sides and stiffness was measured using a unique roi of 2.5 cm².

white matter damage occurs in 20% of preterm infants in industrialized countries. these lesions are difficult to evaluate by standard ultrasound. the quantitative elastography is a new medical imaging technique and potentially a diagnostic tool in brain lesions in preterm infants. shear wave imaging (ssi) could be of interest in this clinical setting. this technique, already investigated in adults (breast, thyroid or liver fibrosis staging), has not been yet evaluated in neonates.

Eligibility criteria:
inclusion criteria: * gestational age between 24 +0 and 31 +6 j ga) and 39 +0 and 40 +6 d (control group) * inborn or outborn * informed consent of the holders of the exercise of parental authority * recipient of a social security system (excluding ame) child exclusion criteria: * malformation known pathology; * known chromosomal abnormality;

Keywords: preterm and term newborns diagnosis of cerebral white matter damage quantitative brain elasticity transfontanel ultrafast doppler
effect of chewing gum in hemodialysis patients

Conditions: Chewing Gum; Hemodialysis

Summary: the aim of this prospective randomized controlled study was to investigate the effects of chewing gum on interdialytic weight gain, thirst, dry mouth and intradialytic symptoms in hemodialysis patients.

the prevalence of xerostomia varies high in patients with chronic hemodialysis (hd), and the decreased saliva flow rate due to various mechanisms is the main factor in its development. the significant decrease in saliva flow due to the atrophy and fibrosis of the salivary glands in hd patients is further affected by the restriction in fluid intake. the use of drugs such as antidepressants, antipsychotics, antihistamines, antihypertensives, aspirin, benzodiazepines, opioids and proton pump inhibitors also leads to hyposalivation and xerostomia. thirst is common in chronic hd patients due to both volumetric and osmometric causes but the primary mechanism is osmometric. the osmolarity of the extracellular fluid increases with the dietary salt and the hypothalamus is stimulated by the shrinkage of the osmoreceptor cells, leading to the desire to ingest liquids. volumetric thirst develops secondary to water and salt loss and the resultant stimulation of cardiac baroreceptors, with the cardiac return volume decreasing gradually towards the end of the hd session. increased interdialytic weight in hd patients causes increased risk of death due to cerebrovascular events and cardiovascular diseases and leads to an increase in morbidity and mortality together with a deterioration of the patient's quality of life. interdialytic weight gain (iwg) causes incompliance with fluid control as a result of the secondary excessive consumption of liquid and food and is an important condition.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * on maintenance hemodialysis three times per week for four hours per session * receiving hemodialysis therapy for a least six moths at the time of the study * able to communicate in turkish * willing to participate to the study exclusion criteria: * 18 years of age younger * absence of psychiatric disorders that cause cognitive dysfunction, such as alzheimer's disease or chronic psychosis. * the patient who took chemotherapy and radiotherapy * have salivary gland infection and dementia * oral and / or dental diseases to prevent chewing gum * unwilling to to participate to the study

Keywords: thirst weight gain